Healthy
Conditions
Brief summary
This is a randomized, single-blind, single and multiple dose crossover subjects in healthy adult subjects
Detailed description
This is a single-center, in-patient, treatment sequence-randomized, single-blind SD and MD crossover study in 27 healthy adult male and female subjects. Subjects will be admitted to the clinic on Day-1 and discharged the morning of Day 5 of each treatment period. Subjects will be on a standard diet during each inpatient treatment period; study drug will be administered in the fasted state for PK assessments on Days 1 and 4 of each treatment period. Subjects will have a follow-up phone call 7 to 10 days after the last dose in Period 3. There will be a 6 to 8 day washout between the last dose in Period 1 and the first dose in Period 2, and between the last dose in Period 2 and the first dose in Period 3.
Interventions
DRUGTolperisone
tablets
Sponsors
Neurana Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Subject)
Intervention model description
sequence randomized
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
* Generally Healthy Subjects * BMI between 18.5 and 32.5 kg/m2
Exclusion criteria
\- pregnant or breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cmax | taken over 4 days per dose | Maximum plasma concentration of tolperisone |
| Tmax | taken over 4 days per dose | Time of maximum plasma concentration of tolperisone |
| AUC | taken over 4 days per dose | Area under the curve of tolperisone plasma concentrations |
| T1/2 | taken over 4 days per dose | Half life of tolperisone |
Countries
United States
Outcome results
None listed